Bard Peripheral Vascular Recalls Hickman and Broviac Catheter Trays Over Sterility Risks

FDA Recalls medium FDA · · Worldwide

Bard Peripheral Vascular Inc. has recalled over 14,000 Hickman and Broviac catheter trays because damaged packaging may compromise the sterile barrier of the devices.

What Happened

Bard Peripheral Vascular Inc. has initiated a voluntary Class II recall of various Hickman and Broviac Central Venous (CV) Catheter trays and kits. The recall was prompted by reports of damage to the outer tray packaging, a defect that can potentially compromise the sterile barrier of the medical equipment.

Which Products Are Affected

A total of 14,935 units are included in this recall. Affected products include various configurations of the following:

  • Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Trays and Kits (Catalog: 60060, 600060, 600520, 0600520CE)
  • Broviac 6.6 Fr Single-Lumen CV Catheter Trays and Kits (Catalog: 600100, 600120, 600540, 0600100CE, 0600540CE)
  • Hickman 7 Fr Dual-Lumen CV Catheter Trays and Kits (Catalog: 600310, 600570, 0600310CE, 0600570CE)
  • Hickman 9.6 Fr Single-Lumen CV Catheter Kits (Catalog: 600560, 0600560CE)
  • Hickman 10 Fr Triple-Lumen CV Catheter Kits (Catalog: 606560, 0606560CE)
  • Hickman 12 Fr Dual-Lumen CV Catheter Trays and Kits (Catalog: 600350, 600620, 0600620CE)
  • Hickman 12.5 Fr Triple-Lumen CV Catheter Kits (Catalog: 600650, 0600650CE)

The recall affects numerous lot numbers distributed nationwide across the United States and internationally to countries including Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, and Vietnam.

What You Should Do

Bard Peripheral Vascular Inc. began notifying customers of the issue via letter on December 12, 2025. Healthcare facilities and distributors should immediately check their inventory for the affected catalog and lot numbers. Affected products should be quarantined and handled according to the specific instructions provided in the firm’s notification letter.

Why This Matters

The integrity of the sterile barrier is critical for medical devices inserted into the central venous system. If the barrier is compromised, patients are at an increased risk of serious infection or other medical complications during or after the catheterization procedure.

Source

This recall is documented by the FDA under recall number Z-1367-2026.

Source: FDA Official Notice